SC2000 and ACUSON X300 Diagnostic Ultrasound Systems— 510(k) K142395
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K142395 for SC2000 and ACUSON X300 Diagnostic Ultrasound Systems, Substantially Equivalent on 2014-09-09. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Moutain View, CA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.